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Tracking Information | |||||
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First Received Date † | February 24, 2006 | ||||
Last Updated Date | October 19, 2007 | ||||
Start Date † | November 2003 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00297349 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures. | ||||
Official Title † | An Open-Label Observation Study Of Topiramate Administration As Adjuvant Therapy For Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures And Generalized Tonoclonic Seizures In Adults And Children Aged 2 Years And Older. | ||||
Brief Summary | The purpose of this study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children. |
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Detailed Description | Topiramate is a medication that is approved for the treatment of seizures. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is an open-label, multi-center observational safety study to collect safety information for oral topiramate given in addition to other medications for 3 types of seizures (focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures and generalized tonic-clonic seizures) in adults and in children aged 2 years and older. Patients whose previous treatment for seizures (one or more antiepileptic drugs) has been judged by their physician to be non-satisfactory will receive 6 months of treatment with topiramate in addition to other antiepileptic medication as prescribed by their physician. Topiramate will be given at low doses initially and gradually increased as necessary to control seizure activity in accordance with Summary of Product Characteristics (SmPC). Patients will be asked to keep a diary of adverse events and seizure activity. Safety evaluations (incidence of adverse events, physical examinations, vital signs and laboratory tests) will be performed throughout the study per investigators daily clinical practice. At the end of the study, the treating physician may continue treatment with topiramate and other medication as appropriate. The study hypothesis is that topiramate given in combination with other antiepileptic medications will be effective in achieving and maintaining control of seizure activity and is well-tolerated. Individualization of the treatment should begin with administration of the drug in the evening, from 25 mg for one week. Subsequently, every week or every two weeks, the dose should be increased by 25-50 mg/day and be taken in two divided doses. Study duration: 6 Months |
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Study Phase | Phase IV | ||||
Study Type † | Observational | ||||
Study Design † | Prospective | ||||
Condition † |
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Intervention † | Drug: topiramate | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 165 | ||||
Completion Date | June 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 2 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00297349 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Janssen Cilag Pharmaceutica S.A.C.I., Greece | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Janssen Cilag Pharmaceutica S.A.C.I., Greece | ||||
Verification Date | October 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |